Healthy
Conditions
Keywords
Radioactive, ADME, Disposition, Bioavailability
Brief summary
The main purpose of this study is to evaluate how much of the study drug (LY3473329), administered as a single dose that has the radioactive substance 14C incorporated into it, passes from blood into urine, feces and expired air in healthy male participants. The study will also measure how much of the study drug gets into the bloodstream when taken orally, compared to when injected directly into the vein, how its broken down, and how long it takes the body to get rid of it. The study is conducted in two parts. The study will last up to approximately 9 and 7 weeks for part 1 and 2, respectively.
Interventions
DRUG[14C]-LY3473329
Administered orally
DRUGLY3473329
Administered orally
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
35 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Male participants who are overtly healthy as determined by medical evaluation * Have a body mass index of 18.0 to 35.0 kilograms per meter squared (kg/m²), inclusive * Males who agree to use highly effective or effective methods of contraception
Exclusion criteria
* Have known allergies to LY3473329, related compounds, or any components of the formulation, or history of significant atopy * Have a history of constipation or have had acute constipation within 3 weeks prior to check-in * Have participated in any clinical study involving a radiolabeled investigational product within 12 months prior to check-in. Any previous radiolabeled study intervention must have been received more than 12 months prior to check-in * Have used or plan to use over-the-counter or prescription medication within 14 days prior to dosing, or any medications or products known to alter drug absorption, metabolism, or elimination processes * Have participated, within the last 3 months, in a clinical study involving an investigational product
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Day 1 up to Day 29 post dose | Part 1: Urinary Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
| Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered | Day 1 up to Day 29 post dose | Part 1: Fecal Excretion of LY3473329 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
| Part 2: Pharmacokinetics (PK): Absolute bioavailability (F) of LY3473329 | Day 1 up to Day 9 post dose | Part 2: PK: F of LY3473329 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Part 2: PK: AUC (0-∞) of [14C]-LY3473329 | Day 1 up to Day 9 post dose | Part 2: PK: AUC (0-∞) of \[14C\]-LY3473329 |
| Part 2: PK: AUC (0-∞) of Total Radioactivity | Day 1 up to Day 9 post dose | Part 2: PK: AUC (0-∞) of Total Radioactivity |
| Part 2: PK: Cmax of LY3473329 | Day 1 up to Day 9 post dose | Part 2: PK: Cmax of LY3473329 |
| Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of LY3473329 | Day 1 up to Day 29 post dose | Part 1: PK: AUC(0-tlast) of LY3473329 |
| Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Last Time Point (AUC[0-tlast]) of Total Radioactivity | Day 1 up to Day 29 post dose | Part 1: PK: AUC(0-tlast) of Total Radioactivity |
| Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of LY3473329 | Day 1 up to Day 29 post dose | Part 1: PK: AUC(0-∞) of LY3473329 |
| Part 2: PK: Cmax of [14C]-LY3473329 | Day 1 up to Day 9 post dose | Part 2: PK: Cmax of \[14C\]-LY3473329 |
| Part 1: PK: Maximum Concentration (Cmax) of LY3473329 | Day 1 up to Day 29 post dose | Part 1: PK: Cmax of LY3473329 |
| Part 1: PK: Maximum Concentration (Cmax) of Total Radioactivity | Day 1 up to Day 29 post dose | Part 1: PK: Cmax of Total Radioactivity |
| Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) | Day 1 up to Day 29 post dose | Part 1: Total Radioactivity Recovered in Urine, Feces, and Expired Air (if applicable) |
| Part 1: Total Number of Metabolites of LY3473329 | Day 1 up to Day 29 post dose | Part 1: Total Number of Metabolites of LY3473329 |
| Part 2: PK: AUC (0-∞) of LY3473329 | Day 1 up to Day 9 post dose | Part 2: PK: AUC (0-∞) of LY3473329 |
| Part 1: PK: Area Under the Curve Concentration Versus Time Curve From Time zero to Infinity (AUC[0-∞) of Total Radioactivity | Day 1 up to Day 29 post dose | Part 1: PK: AUC(0-∞) of Total Radioactivity |
| Part 2: PK: Cmax of Total Radioactivity | Day 1 up to Day 9 post dose | Part 2: PK: Cmax of Total Radioactivity |
| Part 2: Total Radioactivity Recovered in Urine and Feces | Day 1 up to Day 9 post dose | Part 2: Total Radioactivity Recovered in Urine and Feces |
Countries
United Kingdom
Outcome results
None listed